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www.fdanews.com/articles/156410-fda-devicemakers-should-consider-hacking-risks-during-device-design

FDA: Devicemakers Should Consider Hacking Risks During Device Design

June 17, 2013
Premarket submissions for internet-connected medical devices should include cybersecurity risks considered during the product design, established cybersecurity controls and a traceability matrix linking the controls to the risks they mitigate, according to a draft guidance.
Devices & Diagnostics Letter